The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Device Description

The Monarch Platform is intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures. The Monarch Platform enables robotic electro-mechanical articulation and precise control of a flexible bronchoscope under continuous and direct control by a physician operator. The Monarch Platform allows for precise access of the lung anatomy and continuous visualization using the bronchoscope distal tip camera.

The Monarch Platform consists of three major components, (1) Monarch Cart, (2) Monarch Tower, and (3) Monarch Bronchoscope, and working channel instruments and accessories. The Monarch Cart provides support for the robotic arms. It includes up to three robotic arms and the electronic systems required to power and operate the robotic system. The flexible Monarch Bronchoscope has a working channel and a camera at the tip. The working channel of the Bronchoscope is used for irrigation, aspiration and to deliver the working channel instruments.

Additionally, the Monarch Platform includes electromagnetic (EM) navigation that integrates a pre-operative computed tomography (CT) scan into an intra-operative interface. displaying the modeled bronchoscope tip location relative to the preoperative scan anatomy. Two options of field generators are available to enable electromagnetic navigation. The current Monarch Navigation Field Generator and a new Window Field Generator (WFG). The new WFG is being added to increase compatibility of the Monarch system with advanced imaging systems (Cone Beam and Mobile CT).

AI/ML Overview

Here's an analysis of the provided text regarding the Monarch Platform's acceptance criteria and study information:

Device Acceptance Criteria and Performance Study Analysis

The document describes the Monarch Platform, a robotic bronchoscopy system. The premarket notification (K211493) focuses on modifications to an existing cleared device (K193534), specifically the introduction of a "Window Field Generator (WFG)" as an optional accessory and minor software changes. Therefore, the performance data presented is primarily to demonstrate that these changes do not raise new questions of safety or effectiveness compared to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of quantitative acceptance criteria with specific thresholds (e.g., accuracy > 95%). Instead, it generally states that the device was tested to ensure it performs "as intended" and that changes "do not raise different questions of safety or effectiveness."

Here's a summary of the reported device performance based on the general statements:

Aspect Tested	Acceptance Criteria (Implied)	Reported Device Performance
Overall System Performance	Performs as intended, no new safety/effectiveness questions raised by modifications.	"Overall, device performance testing showed that the differences in technological characteristics do not raise different questions of safety or effectiveness."
Electrical Safety	Meets relevant electrical safety standards.	"Verification testing included electrical safety..."
Electromagnetic Compatibility (EMC)	Meets relevant EMC standards.	"...and electromagnetic compatibility..."
Software Functionality	Software changes operate correctly and do not introduce new risks.	"...software, and performance specifications verification testing." (Specifically mentions "minor software changes" including arm kinematics, smoother virtual views, new 'Segmentation Failure' notification trigger, and reduced red saturation in live endoscopy view.)
Window Field Generator (WFG) Functionality	Performs the same function as the existing Monarch Field Generator, with increased mechanical compatibility.	"This new WFG has the same core technological characteristics as the current Monarch Field Generator but is secured under the patient bed to optimize mechanical compatibility. Both EM field generators perform the same function for the Monarch Platform."
Clinical Input Requirements (CIR)	Meets defined CIRs for its intended use.	"confirmatory validation testing was performed to ensure the device meets its Clinical Input Requirements (CIR) for its intended use."
Impact on Workflow	Modifications do not negatively impact the pertinent parts of the workflow.	"Validation Testing included evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists."

2. Sample Size and Data Provenance

The document does not specify the sample size used for the test set. It mentions "evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists," but provides no numbers for patients, cases, or procedures.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin. Given the context of a 510(k) submission for a medical device cleared in the U.S., it's highly likely the data would come from U.S. clinical settings, but this is an inference.

3. Number and Qualifications of Experts

The document states that "accredited bronchoscopists" were involved in the "Validation Testing including evaluations of the pertinent parts of workflow." It does not specify the number of experts or their years of experience/specific qualifications beyond being "accredited bronchoscopists."

4. Adjudication Method

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set or for establishing ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention is made of a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The study described focuses on verifying the safety and effectiveness of device modifications rather than assessing the AI's impact on human reader performance.

6. Standalone Performance (Algorithm Only)

The document does not explicitly state that a standalone (algorithm only without human-in-the-loop performance) study was done for the navigation updates. The "navigation was updated for smoother virtual views when transitioning between predicted airways" and "An additional condition for which a "Segmentation Failure" notification would be triggered" suggest algorithm internal testing, but no formal standalone performance study results are provided in the summary. The Monarch Platform is an integrated robotic system where the navigation is an aid to the physician, not a standalone diagnostic tool.

7. Type of Ground Truth Used

The type of ground truth for the device's performance, particularly for the navigation and segmentation aspects, is not explicitly defined. However, given the context of bronchoscopic visualization and access, the "ground truth" for the device's ability to maintain its intended function would likely involve:

Imaging data: Pre-operative CT scans are used for EM navigation, and live endoscopy views provide real-time visualization.
Expert assessment: "Accredited bronchoscopists" evaluated workflow, implying their professional judgment against clinical standards would serve as a form of ground truth for usability and functional performance.
Engineering specifications: Performance verification against design specifications would constitute a ground truth for many technical aspects.

Pathology or extensive outcomes data are not mentioned as being used for the performance testing described.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for a training set. This is because the submission is for modifications to an already cleared device, and the focus is on verification and validation of the changes, not a de novo AI algorithm development where training data would typically be detailed.

9. How Ground Truth for the Training Set Was Established

Since no training set information is provided, there is no information on how its ground truth would have been established.

Summary

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July 9, 2021

Auris Health, Inc. Shikha Gola Director of Regulatory Affairs 150 Shoreline Drive Redwood, California 94065

Re: K211493

Trade/Device Name: Monarch Platform Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 15, 2021 Received: June 21, 2021

Dear Shikha Gola:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part

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801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Shu-Chen Peng Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211493

Device Name Monarch Platform

Indications for Use (Describe)

The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number K211493

I. SUBMITTER

Address: Auris Health, Inc. 150 Shoreline Drive, Redwood City, CA 94065

Contact Person:

Shikha Gola Director, Regulatory Affairs sgola@its.jnj.com 201-240-3891

Date Prepared: May 11, 2021

II. DEVICE

Manufacturer:	Auris Health, Inc.
Trade/Proprietary Name:	Monarch Platform
Common Name:	Bronchoscope (flexible or rigid) and accessories
Product Code:	EOQ
Regulatory Class:	Class II
Classification:	21 CFR 874.4680 Bronchoscope (flexible or rigid) and accessories
Product Codes:	EOQ, JAK

III. PREDICATE DEVICE(S)

Manufacturer:	Auris Health, Inc.
Trade/Proprietary Name:	Monarch Platform
510(K)	K193534
Classification:	21 CFR 874.4680 Bronchoscope (flexible or rigid) and
	accessories
Product Codes:	EOQ, JAK

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The Monarch Platform and its accessories are intended to provide bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic procedures.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Monarch Platform is substantially equivalent to the predicate device with respect to the device function, design and indications of use. There are no changes to the key components of the Monarch Platform which includes the Monarch Cart, Monarch Tower and Monarch Bronchoscope. The proposed device modifications introduced the Window Field Generator (WFG) as an optional accessory for customers for increased mechanical compatibility with advanced imaging systems. This new WFG has the same core technological characteristics as the current Monarch Field Generator but is secured under the patient bed to optimize mechanical compatibility. Both EM field generators perform the same function for the Monarch Platform. Minor software changes were also made to the arm kinematics to better accommodate high patient bed heights. Additionally, navigation was updated for smoother virtual views when transitioning between predicted airways. These updates helped improve the navigation image displayed on the user interface. An additional condition for which a "Segmentation

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Failure" notification would be triggered during the procedure planning step was also added. Lastly the red saturation in the live endoscopy view was reduced to better reflect real tissue coloration. These changes did not impact the core technological characteristics of the Monarch Platform.

DeviceCharacteristics	Predicate DeviceAuris Health, Inc.Monarch Platform (K193534)	Subject Device (K211493)
Regulation Number	21 CFR §874.4680, Bronchoscope(flexible or rigid) and accessories	Same
Class	II	Same
Product Code	EOQ, Bronchoscope (Flexible OrRigid)	Same
Intended Use	JAK, System, X-Ray,Tomography, ComputedThe Monarch Platform and itsaccessories are intended toprovide bronchoscopicvisualization of and access topatient airways for diagnostic andtherapeutic procedures.	Same
Contraindications forUse	Contraindications include but arenot limited to:• Patient whose general health orrespiratory function or both arecompromised to the point that thepatient would not tolerate flexiblebronchoscopy.• Absence of a trainedbronchoscopist to perform orclosely and directly supervise theprocedure, as well as managecomplications common to flexiblebronchoscopy.• Use of the system in patientswith electrically or magneticallyactivated implanted medicaldevices	Same

VII. PERFORMANCE DATA

Verification and validation testing for the new Window Field Generator and the Monarch system were conducted to ensure that the system performs as intended and to ensure the changes outlined in this submission do not raise different questions of safety or effectiveness. Verification testing included electrical safety and electromagnetic

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compatibility, software, and performance specifications verification testing. In addition to design verification, confirmatory validation testing was performed to ensure the device meets its Clinical Input Requirements (CIR) for its intended use. Validation Testing included evaluations of the pertinent parts of workflow impacted by this change with accredited bronchoscopists. Overall, device performance testing showed that the differences in technological characteristics do not raise different questions of safety or effectiveness.

VIII. CONCLUSION

The modified device in this submission does not affect the intended use of the device or alter the fundamental scientific technology of the device. Summary information for the design control process serves as the basis for this submission. The Monarch Platform is substantially equivalent to the legally marketed predicate device based upon intended use, technological characteristics and performance testing.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.